Medical Writing Analyst – Start-Up

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Manage sponsor inquiries with the necessary detail while adhering to current legislation;

• Engage in discussions to determine the most effective strategy for various projects;

• Assist in evaluating project feasibility;

• Aid in identifying potential risks and opportunities for projects resulting from changes in legislation or applicable requirements;

• Conduct literature searches to create clinical study documents, scientific-regulatory opinions, systematic literature reviews, and Investigator Brochures;

• Draft protocols and documents related to clinical studies;

• Prepare Investigator Brochures;

• Compile systematic literature reviews;

• Author and assess clinical and non-clinical modules (CTD format) of documentation for drug registration and post-registration;

• Revise documents as necessary following feedback from project stakeholders;

• Assemble the complete project dossier for submission to the Ethics Committee System (CEP/CONEP) via Plataforma Brasil;

• Prepare amendments, notifications, interim reports, protocol deviations, or responses to inquiries issued by the CEP/CONEP system;

• Address internal monitoring/audits conducted by the Quality Assurance department;

• Contribute to technical responses to inquiries raised by relevant authorities;

• Organize project documents in compliance with internal procedures;

• Maintain the project database in alignment with internal policies;

• Draft and/or review Standard Operating Procedures pertinent to the department and assist, if required, in managing the training matrix for the area;

• Provide support to other analysts within the department;

• Attend Regulatory and Scientific Affairs meetings and other meetings as needed;

• Participate in technical meetings with sponsors and regulatory authorities alongside the Regulatory and Scientific Affairs Management, when necessary;

• Stay informed about regulations and technical requirements relevant to the Brazilian regulatory agency and international guidelines for planning, executing, and submitting projects;

• Represent the company before professional organizations and engage in specific technical groups when the subject significantly impacts the company and/or sponsors.

⛳️ Requirements

• Bachelor's degree in Pharmaceutical Biochemistry, Biomedicine, Biology, Biotechnology, or related fields;

• Proficiency in medical writing;

• Capability to conduct meetings for scientific discussions and present findings;

• Advanced proficiency in English;

• Basic understanding of Spanish;

• Advanced skills in MS Office;

• Training in Good Clinical Practice (GCP);

• Desirable knowledge of systematic literature review;

• Prior experience in medical writing for clinical research.

🏝️ Benefits

• Commuting allowance (Vale Transporte);

• Parking (subject to availability);

• Health insurance with no monthly premium for the employee; co-pay applies for tests and consultations;

• Dental plan with co-pay;

• Life insurance at no cost to the employee;

• Flexible meal/food allowance;

• Pharmacy discount program;

• Vaccination program;

• Synvia Partnership Club (discounts with educational institutions, language schools, leisure, and cultural services);

• Flexible time bank — holidays and commemorative dates (per internal policy);

• Partnership with SESC;

• Physical wellness program — TotalPass;

• Day off — health professional;

• Childcare allowance (per internal policy).